A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps

Straumann

Status: Withdrawn

Conditions: Tooth Loss

Treatments: Device: ESTA abutment Roxolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219139

CIV-12-10-009101 (Other Identifier)

CR 03/10 ESTA

Details and patient eligibility

About

Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.

Full description

One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.

Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.

The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must have voluntary signed the informed consent form before any study related action.
• Males and females with at least 18 years of age
• Non-smokers
• Straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the maxilla or mandible with thick tissue biotype
• Adequate oral hygiene (Full mouth plaque index; O'Leary, et al. 1972) <25% at abutment placement
• The patient must be able to open the mouth to allow removal of the abutment at the planned abutment site

Exclusion criteria

• Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
• Any antibiotic treatment or anti-inflammatory treatment within the past 2 month
• Any contraindications for oral surgical procedures
• Mucosal diseases (e.g. lichen planus, mouth ulcer)
• History of local irradiation therapy
• Current treated (within the last 12 month) or untreated periodontitis
• Current treated (within the last 6 month) or untreated gingivitis
• Probing pocket depth of ≥4 mm on one of the teeth immediately adjacent to the dental implant site
• Severe bruxing or clenching habits
• Lack of primary stability of the implant at abutment placement
• Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
• Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
• Physical or mental handicaps that would interfere with the ability to follow protocol procedures
• Pregnant or breastfeeding wome
• Insufficient soft tissue attachment to the neck of the abutment (e.g. visibility of the abutment platform or exposed ESTAnsurface) after abutment placement

Trial design

0 participants in 1 patient group

ESTA abutment Roxolid

Other group

Description:

One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks. Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene. The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration.

Treatment:

Device: ESTA abutment Roxolid